Device product
iStat1 Analyzer Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of arterial, venous, or capillary whole blood Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels.
Z-1973-2012
Product summary
- Event
- Event 62319
- Status
- Terminated
- Classification
- Class II
- Quantity
- 06F16-05-45 units; 06F16-10-22289units; ;310000-4393 units; 310001-1139 units; 310002-11489 units
- Official record key
device-enforcement:Z-1973-2012
Official wording
Reason: Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
Code information: 510K K940918 Product Number/List Number 06F16-05; 06F16--10; 310000; 310001;; 310002 All lots
Distribution pattern: Worldwide Distribution - USA (nationwide)
Derived failure modes
-
Unknown
Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.